BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL

    MDR report key: 6335021 · Received February 16, 2017

    Report

    Report Number
    3002808486-2017-00455
    Event Type
    Malfunction
    Date Received
    February 16, 2017
    Date of Event
    May 28, 2015
    Report Date
    May 28, 2015
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    KRD
    UDI-DI
    00827002202337
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR TO DEVICE UNDER 510(K) K063619. SUMMARY OF INVESTIGATIONAL FINDINGS: VISUAL INSPECTION FOUND THAT THE TWO COILS WERE ELONGATED, UNRAVELED AND KINKED. ONE COIL WAS STILL IN THE LOADING CARTRIDGE AND THE OTHER COIL WAS ESPECIALLY ELONGATED AND UNABLE TO COIL UP. IT WAS NOT POSSIBLE TO INSERT STRAIGHTENING MANDRIL INTO THE COILS AND MAKE A FURTHER INSPECTION, DUE TO THE DAMAGE OF THE COILS. UNKNOWN WHICH CATHETERS WERE USED, THEREFORE DIFFICULT TO DETERMINE IF THIS HAD ANY IMPACT TO THE ADVANCEMENT DIFFICULTIES. IN DESCRIPTION OF EVENT IT IS NOTED "PDA COIL IN DIFFERENT DIAMETER, "IMWCE-3-PDA4" ATTACHED TO A NEW TDS COULD BE ADVANCED WITHOUT PROBLEMS AND THE PROCEDURE WAS COMPLETED." HOWEVER, "-PDA4" INDICATES THE DIAMETER OF THE COILED WIRE AND SINCE BOTH PDA COILS ARE MANUFACTURED WITH SAME WIRE DIAMETER, CHANGING THE COIL SHOULD NOT HAVE ANY IMPACT WHEN ADVANCING THE STRAIGHTENED COIL. VISUAL INSPECTION OF THE TDS ((B)(4)) SHOWED NO ISSUES WITH THE THREAD OF THE DELIVERY WIRE, HOWEVER THE RETURNED STRAIGHTENING MANDRIL WAS PULLED BACKWARDS APPROXIMATELY 15 CM AND CONSEQUENTLY DID NOT PROTRUDE THROUGH THE THREAD OF THE DELIVERY WIRE, WHICH ACCORDING TO IFU IS VERY IMPORTANT FOR THE LOADING PROCEDURE. NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. ALL COILS ARE INSPECTED 100%. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A PATIENT UNDERWENT TREATMENT OF PDA (PATENT DUCTUS ARTERIOSUS). AFTER A CATHETER WAS ADVANCED TO THE TARGET SITE, THE PHYSICIAN ATTEMPTED TO INSERT A IMWCE-3-PDA5 ((B)(4)) ATTACHED TO A TDS-110-PDA ((B)(4)) INTO THE CATHETER. HOWEVER, WHEN THE COIL WAS PUSHED INTO THE CATHETER FROM THE LOADING CARTRIDGE, RESISTANCE STRONGER THAN USUAL WAS FELT, AND IN ADDITION, THE COIL WOULD NOT ADVANCE FURTHER THROUGH THE CATHETER AT ALL. THEREFORE, THE CATHETER AND THE ASSEMBLY OF TDS AND PDA COIL WERE RETRIEVED AND A NEW CATHETER WAS INSERTED INTO THE PATIENT'S BODY, THROUGH WHICH ADVANCEMENT OF SECOND AND THIRD IMWCE-3-PDA5 IN THE SAME LOT # WAS ATTEMPTED. HOWEVER, THE RESULT WAS THE SAME; RESISTANCE STRONGER THAN USUAL WAS ENCOUNTERED IN PUSHING THE COIL INTO THE INNER LUMEN OF THE CATHETER FROM THE LOADING CARTRIDGE, AND THE ADVANCEMENT OF THE COIL THROUGH THE CATHETER WAS IMPOSSIBLE. SO, THE PHYSICIAN RETRIEVED THE DEVICES AND INSERTED A NEW CATHETER INTO THE PATIENT'S BODY ONCE AGAIN, THROUGH WHICH A PDA COIL IN DIFFERENT DIAMETER, "IMWCE-3-PDA4" COULD BE ADVANCED WITHOUT PROBLEMS THIS TIME, AND THE PROCEDURE WAS COMPLETED. CORRECTIVE INFORMATION RECEIVED 04JUN2015: AFTER A CATHETER WAS ADVANCED TO THE TARGET SITE, THE PHYSICIAN ATTEMPTED TO INSERT A IMWCE-3-PDA5 ((B)(4)) ATTACHED TO A TDS-110-PDA ((B)(4)) INTO THE CATHETER. HOWEVER, WHEN THE COIL WAS PUSHED INTO THE CATHETER FROM THE LOADING CARTRIDGE, RESISTANCE STRONGER THAN USUAL WAS FELT, AND IN ADDITION, THE COIL GOT STUCK AT THE HUB OF THE CATHETER AND WOULD NOT ADVANCE FURTHER AT ALL. THEREFORE, THE ASSEMBLY OF TDS AND PDA COIL WERE RETRIEVED OUT OF THE BODY (ONLY THE CATHETER WAS REMAINED) AND THE SECOND IMWCE-3-PDA5 OF THE SAME LOT # AND THE SECOND TDS-110-PDA IN THE SAME LOT# WERE NEWLY USED. HOWEVER, THE RESULT WAS THE SAME; RESISTANCE STRONGER THAN USUAL WAS ENCOUNTERED IN PUSHING THE COIL INTO THE CATHETER FROM THE LOADING CARTRIDGE, THE COIL GOT STUCK AT THE HUB OF THE CATHETER AND THE COIL BECAME IMPOSSIBLE TO ADVANCE FURTHER. SO, TAKING THE POSSIBILITY OF THE DEFECTS OF THE CATHETER INTO THE CONSIDERATION, WHOLE DEVICES INCLUDING THE CATHETER WERE WITHDRAWN OUT OF THE BODY THIS TIME. AFTER THAT, A NEW CATHETER OF THE SAME SPECIFICATION AS THE PREVIOUSLY USED ONE WAS ADVANCED INTO THE LESION AND THEN, ADVANCEMENT OF THE THIRD IMWCE-3-PDA5 ATTACHED TO THE PREVIOUSLY USED SECOND TDS-110-PDA (THIS TIME TDS WAS NOT REPLACED) WAS ATTEMPTED. HOWEVER, THE RESULT WAS THE SAME AFTER ALL; RESISTANCE STRONGER THAN USUAL WAS ENCOUNTERED WHEN PUSHING THE COIL INTO THE CATHETER FROM THE LOADING CARTRIDGE, THE COIL GOT STUCK AT THE HUB OF THE CATHETER AND IT BECAME IMPOSSIBLE TO ADVANCE THE COIL FURTHER. THUS, THE PHYSICIAN RETRIEVED ALL THE DEVICES, AND THEN INSERTED A NEW CATHETER OF THE SAME SPECIFICATION AS THE PREVIOUSLY USED TWO CATHETERS INTO THE PATIENT'S BODY ONCE AGAIN, THROUGH WHICH A PDA COIL IN DIFFERENT DIAMETER, "IMWCE-3-PDA4" ATTACHED TO A NEW TDS COULD BE ADVANCED WITHOUT PROBLEMS AND THE PROCEDURE WAS COMPLETED. AS FOR TWO COILS OUT OF THE THREE RELEVANT ONES, THOUGH ATTACHMENT OF THE TDS AND THE COIL COULD BE PERFORMED, STRAIGHTENING MANDRIL OF TDS COULD NOT BE INSERTED ALL THE WAY INSIDE THE COIL, BUT IT GOT STUCK IN THE COIL AND COULD NOT BE ADVANCED FURTHER. PATIENT OUTCOME: NO ADVERSE EFFECTS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119783 MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD WILLIAM COOK EUROPE 00827002202337

    Patients

    Seq Age Sex Outcome Treatment
    1